Food, drugs, devices › Abbott Laboratories
Device recall: Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL
FDA enforcement event 71244 is a device recall by Abbott Laboratories of Abbott Park, IL, initiated 11 May 2015 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 27 Jun 2016. Initiation: voluntary: firm initiated. Abbott Laboratories has 46 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Abbott Laboratories, Abbott Park, IL.
Reason for recall
"The product is leaking from the cap and crystallization was noted as present around the cap."
Distribution
"Worldwide Distribution - US (nationwide), Mexico, Colombia, Brazil, Germany, Hong Kong, Belgium, Czech Republic, Finland, Hungary, Ireland, China, New Zealand, Uruguay, Puerto Rico, St. Lucia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1725-2015 | Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use. | 8868 units | Class II | Terminated | 17 Jun 2015 |
Context
Other enforcement events for Abbott Laboratories
All 46 events for Abbott Laboratories
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The product is leaking from the cap and crystallization was noted as present around the cap."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US (nationwide), Mexico, Colombia, Brazil, Germany, Hong Kong, Belgium, Czech Republic, Finland, Hungary, Ireland, China, New Zealand, Uruguay, Puerto Rico, St. Lucia,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Jun 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.